News Category: Regulatory news
The HPRA is participating in phase 2 of the Simultaneous National Scientific Advice (SNSA) Pilot, which has been launched by the EU-Innovation Network. The SNSA pilot is open to applicants (including pharmaceutical companies, SMEs or academic researchers) who wish to obtain national scientific advice related to medicinal products from more than one national competent authority (NCA) at the same time.
In conjunction with the Accelerating Clinical Trials in the EU (ACT EU) initiative, phase 2 of the SNSA pilot will have a specific focus on scientific advice to facilitate clinical trials (CT) within Europe. It will facilitate sponsors / developers to obtain clinical trial-related national scientific advice from NCAs in member states where they intend to perform clinical trials. SNSA can also be used in other scenarios falling within the scope of national scientific advice, e.g. scientific advice related to a planned decentralised or mutual recognition marketing authorisation application.
Within each SNSA procedure, the participating NCAs will prepare and discuss their positions on the questions raised by the applicant with a view to maximising alignment. A joint advice meeting will then be held between the participating NCAs and the applicant to discuss the questions raised in the scientific advice request. The outcome of each SNSA procedure will be documented in consolidated meeting minutes reflecting the position of each participating NCA.
Applying for scientific advice under the pilot scheme
Applicants wishing to apply for advice under the SNSA pilot should review the information relating to SNSA on the Heads of Medicines Agencies website and refer to the following items:
Queries
For any additional information, please email the SNSA central contact point SNSA@pei.de or the HPRA’s innovation office innovationoffice@hpra.ie.